No Time to Pause: Physical Activity to Improve Health of Midlife Hispanic Women

No Time to Pause: Physical Activity to Improve Health and Well-being of Midlife Hispanic Women During the Menopausal Transition

This study will test the effects of a physical activity intervention among midlife Hispanic women.

Study Overview

• Status: Not yet recruiting
• Conditions: Elevated Blood Pressure; Perimenopause
• Intervention / Treatment: Behavioral: Physical activity intervention

Detailed Description

The menopausal transition in midlife is a critical juncture where women experience life transitions and adverse physiological and psychological changes that increase the risk for hypertension and cardiovascular diseases in later life. Physical activity improves blood pressure, biomarkers of hypertension, sleep, mood, and well-being; however, Hispanic women meet physical activity recommendations at lower levels than non-Hispanic White women. The investigator will examine the feasibility of the physical activity intervention among sedentary midlife Hispanic women in the menopausal transition with elevated blood pressure, exploring changes in physical activity and health.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Thibodeaux, BSN, RNC-OB; Phone Number: 409-747-1756; Email: lbthibod@utmb.edu

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch, Galveston
      • Contact: Lisa Thibodeaux; Email: lbthibod@utmb.edu
      • Principal Investigator: Elizabeth Lorenzo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female
2. Hispanic by self-report
3. Able to speak and read English
4. Sedentary
5. Age 45-50
6. Diagnosed with elevated blood pressure or objectively measured systolic blood pressure 120-139 mmHg and/or diastolic blood pressure 80-89 mmHg averaged from ≥ 2 measures on ≥ 2 outpatient visits
7. Symptoms consistent with the menopause transition (persistent difference of ≥7 days in the length of consecutive cycles; persistence is defined as recurrence within 10 cycles of the first variable length cycle)
8. Apparently healthy
9. Self-reported ability to engage in moderate intensity physical activity
10. Access to a smart device that is compatible with a Fitbit application

Exclusion Criteria:

1. Self-reported physical activity of ≥150 minutes per week
2. Answered yes to any question on the Physical Activity Readiness (PAR-Q+) questionnaire
3. Post-menopausal (12-months without a menstrual cycle)
4. Diagnosed hypertension
5. Cardiovascular, respiratory, neurological, renal, endocrine, gastrointestinal and/or psychiatric diseases, or any cancers
6. Previous hysterectomy, oophorectomy, and/or uterine ablation
7. Medication to treat hypertension, elevated glucose, cholesterol, depression, anxiety, and insomnia
8. Hormonal medication via any route or implants
9. Tamoxifen
10. Pregnant, planning to become pregnant, or breastfeeding
11. Planning to move out of the Galveston/Houston area in the next 18 months
12. Current participation in another physical activity study or program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical activity intervention; Multi-level intervention to increase physical activity	Behavioral: Physical activity intervention; Physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days the activity monitor was worn	Objectively measured days the wearable activity monitor was worn during the intervention period	Baseline to 6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months	Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period	Baseline to 6-months
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months	Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period	Baseline to 12-months
Physical activity as measured by minutes of moderate intensity physical activity at 6 months	Mean daily minutes of moderate intensity physical activity taken from accelerometers for a 7 day period	Baseline to 6-months
Physical activity as measured by minutes of moderate intensity physical activity at 6 months	Mean daily minutes of moderate intensity physical activity taken from accelerometers for a 7 day period	Baseline to 12-months
Physical activity as measured by minutes of vigorous intensity physical activity at 6 months	Mean daily minutes of vigorous intensity physical activity taken from accelerometers for a 7 day period	Baseline to 6-months
Physical activity as measured by minutes of vigorous intensity physical activity at 6 months	Mean daily minutes of vigorous intensity physical activity taken from accelerometers for a 7 day period	Baseline to 12-months
Physical activity as measured by minutes of light intensity physical activity at 6 months	Mean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period	Baseline to 6-months
Physical activity as measured by minutes of light intensity physical activity at 6 months	Mean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period	Baseline to 12-months
Physical activity as measured by minutes of total physical activity at 6 months	Mean daily minutes of total physical activity taken from accelerometers for a 7 day period	Baseline to 6-months
Physical activity as measured by minutes of total physical activity at 6 months	Mean daily minutes of total physical activity taken from accelerometers for a 7 day period	Baseline to 12-months
Systolic blood pressure	Change in systolic blood pressure (mmHg)	Baseline to 6-months
Systolic blood pressure	Change in systolic blood pressure (mmHg)	Baseline to 12-months
Diastolic blood pressure	Change in diastolic blood pressure (mmHg)	Baseline to 6-months
Diastolic blood pressure	Change in diastolic blood pressure (mmHg)	Baseline to 12-months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal circumference	Change in abdominal circumference (cm)	Baseline to 6-months
Abdominal circumference	Change in abdominal circumference (cm)	Baseline to 12-months
Body mass index	Change in body mass index (kg/m2)	Baseline to 6-months
Body mass index	Change in body mass index (kg/m2)	Baseline to 12-months

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Elizabeth Lorenzo, PhD, RN, University of Texas

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Physical activity; Behavior change; Women's health; Minority health; Hypertension prevention
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Behavior; Hypertension; Motor Activity
• Other Study ID Numbers: 23-0320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The research data from this project will be deposited with a service of the Inter-university Consortium for Political and Social Research (ICPSR), openICPSR, to ensure that the research community has long-term access to the data.
• IPD Sharing Time Frame: We agree to deposit and/or make available our data upon completion of the clinical trial and acceptance of the data for publication. Data will be stored in the repository for at least 3 years, as required by federal retention guidelines.
• IPD Sharing Access Criteria: Data will be shared via openICPSR as open access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No